Forward to: Clinical Operations

Clinical Trial
Intelligence Workflows

Ten agent workflows for Clinical Operations — trial design monitoring, enrollment tracking, endpoint analysis, site selection intelligence, CRO performance monitoring, regulatory requirement tracking, data readout prediction, patient recruitment optimization, competitive enrollment intelligence, and clinical trial dashboard — enabling data-driven clinical decisions powered by comprehensive domain intelligence.

1Clinical Trial Registry Monitoring

AI agent monitors clinical trial registries and competitor domains to track new trial initiations, protocol amendments, enrollment status, and data readout timelines across therapeutic areas.

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Track Competitor Clinical Trials
/products/investors/pressCountries
CLINICAL TRIAL INTELLIGENCE — 2,400 TRIALS MONITORED ════════════════════════════════════════════════════════ novartis.com /products: CRISPR gene therapy trial — sickle cell Phase 3 /investors: 14 pivotal trials with data in 2026 /press: Enrollment complete 3 months ahead of schedule SIGNAL: Novartis accelerating — our competing program 6 months behind lilly.com /products: Donanemab Phase 3 extension — 18-month follow-up data /press: Real-world evidence supporting sustained benefit /investors: 4 new Phase 3 initiations in immunology astrazeneca.com /products: Dato-DXd (ADC) — 3 tumor types in Phase 3 /press: Primary endpoint missed in 1 of 3 indications SIGNAL: AZ ADC setback — opportunity in that indication

2Enrollment & Recruitment Intelligence

AI agent monitors patient recruitment platforms, clinical trial sites, and enrollment analytics to optimize patient recruitment strategies and accelerate trial timelines.

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Optimize Trial Enrollment
/products/about/pressIAB Categories
ENROLLMENT INTELLIGENCE ════════════════════════════════════════════════════════ antidote.me — Patient matching platform /products: AI-powered trial matching — 4M patients registered /case-studies: 42% enrollment acceleration for oncology trials SIGNAL: Deploy for our 3 recruiting oncology trials trialspark.com /products: Decentralized trial platform — home visits + telemedicine /press: Diversity enrollment improved 55% with decentralized model SIGNAL: Address FDA diversity mandate with decentralized sites OUR ENROLLMENT STATUS: Trial ABC-301 (Phase 3): 78% enrolled — on track Trial DEF-201 (Phase 2): 42% enrolled — 4 months behind Trial GHI-101 (Phase 1): Complete ACTION: Activate 8 additional sites for DEF-201 immediately

3CRO Performance Monitoring

AI agent monitors contract research organization domains to assess capabilities, track performance metrics, detect financial health signals, and inform CRO selection and management.

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Assess CRO Capabilities
/products/investors/careersOpenPageRank
CRO INTELLIGENCE — 85 CROS TRACKED ════════════════════════════════════════════════════════ iconplc.com — ICON /investors: Revenue $8.1B — backlog $22B /products: Decentralized trial capabilities expanded /careers: +22% clinical monitors — capacity growing SIGNAL: Strong capacity — RFP for Phase 3 oncology trial medpace.com /investors: Revenue $2.1B — fastest-growing mid-tier CRO /products: Full-service including biostatistics /careers: High turnover in project management — risk flag parexel.com /press: Acquisition by Goldman Sachs PE — leadership transition SIGNAL: Monitor for service disruption during ownership change

4Data Readout Prediction

AI agent analyzes competitor trial timelines, enrollment completion signals, and investor call transcripts to predict upcoming clinical data readouts that could impact our competitive position.

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Predict Competitor Data Readouts
/investors/press/eventsOpenPageRank
DATA READOUT PREDICTION — NEXT 6 MONTHS ════════════════════════════════════════════════════════ HIGH IMPACT ON OUR PROGRAMS: Mar 2026 merck.com — Keytruda + new combo Phase 3 (lung) Apr 2026 regeneron.com — Dupixent COPD Phase 3 topline May 2026 lilly.com — Orforglipron oral GLP-1 Phase 3 MEDIUM IMPACT: Mar 2026 gilead.com — Trodelvy combo breast cancer Jun 2026 bms.com — CELMoD Phase 2 multiple myeloma STRATEGIC IMPLICATIONS: Merck Keytruda combo: If positive, narrows our lung cancer opportunity Lilly oral GLP-1: If positive, transforms obesity market — existential threat ACTION: Prepare contingency strategies for top 3 readouts

5Site Selection Intelligence

AI agent monitors clinical trial site networks, investigator databases, and regional enrollment capabilities to optimize site selection for new and ongoing trials.

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Optimize Site Selection
/about/products/pressCountries
CLINICAL TRIAL SITE INTELLIGENCE ════════════════════════════════════════════════════════ mdanderson.org — Top cancer center /about: 1,400 active clinical trials — highest in US /press: New early-phase unit — 80 additional slots SIGNAL: First-in-human oncology capacity available — secure slots curebase.com — Decentralized trial network /products: 2,400 sites — home nursing + telemedicine /case-studies: Rural enrollment 3.2x higher with DCT model SIGNAL: Add DCT sites for diversity requirements OUR SITE PERFORMANCE RANKINGS: Top enrollers: 12 sites (contributing 68% of patients) Underperformers: 8 sites (contributing only 4%) ACTION: Close 5 underperforming sites + activate 8 high-potential

6Regulatory Endpoint Intelligence

AI agent monitors FDA and EMA guidance documents, advisory committee meetings, and precedent decisions to inform clinical trial endpoint selection and regulatory strategy.

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Track Endpoint Regulatory Guidance
/docs/press/complianceCountries
REGULATORY ENDPOINT INTELLIGENCE ════════════════════════════════════════════════════════ fda.gov /docs: Updated guidance — patient-reported outcomes as co-primary /press: Accelerated approval pathway expanded for rare diseases /compliance: Real-world evidence accepted for supplemental indications SIGNAL: RWE pathway could save 2 years on line extension ema.europa.eu /docs: New oncology endpoints guidance — OS still preferred /press: EMA tightening accelerated assessment criteria ACTION: Review Phase 3 endpoints against updated EMA guidance ENDPOINT TRENDS: PROs as co-primary: Growing — 28% of recent approvals Surrogate endpoints: Under scrutiny — post-market requirements Digital endpoints: 3 FDA acceptances in 2025 — emerging

7Trial Technology Innovation

AI agent monitors clinical trial technology companies to track innovations in decentralized trials, electronic data capture, wearables, and AI-powered clinical analytics.

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Track Clinical Technology Innovation
/products/press/case-studiesDomain Age
CLINICAL TRIAL TECHNOLOGY LANDSCAPE ════════════════════════════════════════════════════════ medidata.com — Dassault Systemes /products: Rave platform — AI-powered data quality monitoring /press: Synthetic control arms accepted by FDA in 2 trials SIGNAL: Synthetic control could reduce Phase 3 size 30% scienceio.com /products: AI clinical document understanding /case-studies: 85% reduction in data abstraction time Domain Age: 1,820 days | PageRank: 4.2 unlearn.ai /products: Digital twin technology for trial optimization /press: FDA agreed to 30% sample size reduction using digital twins SIGNAL: Evaluate for Phase 3 trials — potential $15M savings per trial

8Diversity in Clinical Trials

AI agent monitors FDA diversity requirements, competitor diversity plans, and community engagement platforms to ensure clinical trials meet evolving diversity and inclusion standards.

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Track Diversity Requirements
/compliance/press/aboutCountries
CLINICAL TRIAL DIVERSITY INTELLIGENCE ════════════════════════════════════════════════════════ fda.gov /compliance: Diversity Action Plans now required for Phase 3 /press: 2 CRLs cited inadequate diversity in 2025 ALERT: FDA rejecting approvals for poor diversity — compliance critical OUR TRIAL DIVERSITY STATUS: Trial ABC-301: Black/AA 8% (disease prevalence 15%) Trial DEF-201: Hispanic 4% (target 12%) ACTION: Activate community health center sites + DCT model BEST PRACTICES: lilly.com: Clinical Trial Diversity initiative — model program genentech.com: Community engagement hubs — 45% diversity improvement RECOMMENDATION: Adopt Genentech community engagement model

9Post-Market Study Intelligence

AI agent monitors post-market study requirements, real-world evidence platforms, and registry studies to inform post-approval commitments and lifecycle management.

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Track Post-Market Requirements
/compliance/docs/productsOpenPageRank
POST-MARKET STUDY INTELLIGENCE ════════════════════════════════════════════════════════ fda.gov /compliance: 168 active post-market requirements for our products /docs: 3 overdue PMR milestones — FDA warning possible ALERT: Complete overdue PMR submissions within 30 days flatiron.com — Real-world data platform /products: Oncology RWD — 300+ cancer centers /press: FDA accepted Flatiron RWE for label expansion SIGNAL: Use Flatiron for post-market evidence generation PMR/PMC STATUS: Active requirements: 168 | On track: 142 Pending: 23 | Overdue: 3 ACTION: Prioritize 3 overdue PMRs — escalate to SVP level

10Clinical Trial Dashboard

AI agent synthesizes all clinical intelligence into an executive dashboard — providing leadership with real-time visibility into trial performance, competitive readouts, and enrollment status.

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Generate Clinical Intelligence Dashboard
/products/investors/pressOpenPageRankCountries
CLINICAL TRIAL DASHBOARD — FEBRUARY 2026 ════════════════════════════════════════════════════════ TRIAL PORTFOLIO: Active trials: 24 | Sites: 840 | Countries: 32 Enrollment: 68% average (target 85%) COMPETITOR READOUTS (NEXT 6 MO): High-impact: 3 readouts threatening our programs Medium-impact: 4 | Low-impact: 12 OPERATIONAL: CRO performance: ICON leading | Medpace turnover risk Diversity compliance: 2 trials below target PMR status: 3 overdue
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Generate Clinical Report

Clinical Trial Report — February 2026

EXECUTIVE SUMMARY ──────────────────────────────────────── Competitor trials monitored: 2,400 CROs tracked: 85 domains Clinical technology companies: 42 domains Regulatory agencies: 8 domains KEY INSIGHTS Enrollment is behind target — DEF-201 needs 8 additional sites immediately. Three competitor data readouts in next 6 months could reshape our competitive position. FDA diversity requirements now enforced with CRLs — 2 trials need intervention. Digital twin technology could save $15M per Phase 3 trial. Three overdue PMRs require immediate escalation.
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